WO2017189807A1 - Système et procédé de suppression du bruit de signaux électrocardiographiques (ecg) - Google Patents

Système et procédé de suppression du bruit de signaux électrocardiographiques (ecg) Download PDF

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Publication number
WO2017189807A1
WO2017189807A1 PCT/US2017/029770 US2017029770W WO2017189807A1 WO 2017189807 A1 WO2017189807 A1 WO 2017189807A1 US 2017029770 W US2017029770 W US 2017029770W WO 2017189807 A1 WO2017189807 A1 WO 2017189807A1
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WO
WIPO (PCT)
Prior art keywords
patient
conductive material
capacitors
ecg
filtering circuitry
Prior art date
Application number
PCT/US2017/029770
Other languages
English (en)
Inventor
Bruno Fazi
Jason Palmer
Original Assignee
Bayer Healthcare Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bayer Healthcare Llc filed Critical Bayer Healthcare Llc
Priority to EP17722602.4A priority Critical patent/EP3448242A1/fr
Publication of WO2017189807A1 publication Critical patent/WO2017189807A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7203—Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal
    • A61B5/7217—Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal of noise originating from a therapeutic or surgical apparatus, e.g. from a pacemaker
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/339—Displays specially adapted therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6802—Sensor mounted on worn items
    • A61B5/6804—Garments; Clothes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7203—Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal
    • H—ELECTRICITY
    • H03—ELECTRONIC CIRCUITRY
    • H03H—IMPEDANCE NETWORKS, e.g. RESONANT CIRCUITS; RESONATORS
    • H03H7/00—Multiple-port networks comprising only passive electrical elements as network components
    • H03H7/004—Capacitive coupling circuits not otherwise provided for
    • H—ELECTRICITY
    • H03—ELECTRONIC CIRCUITRY
    • H03H—IMPEDANCE NETWORKS, e.g. RESONANT CIRCUITS; RESONATORS
    • H03H7/00—Multiple-port networks comprising only passive electrical elements as network components
    • H03H7/01—Frequency selective two-port networks
    • H03H7/0138—Electrical filters or coupling circuits
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6831—Straps, bands or harnesses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7225—Details of analog processing, e.g. isolation amplifier, gain or sensitivity adjustment, filtering, baseline or drift compensation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/14546—Front-loading type injectors

Definitions

  • the present disclosure relates to systems and methods for suppressing noise generated in an electrocardiographic (ECG) signal displayed on an ECG monitor due to external electrical equipment and, more particularly, to the suppression of noise generated in an ECG signal due to the presence of a powered injector in the vicinity of a patient.
  • ECG electrocardiographic
  • Angiography is used generally in the detection and treatment of abnormalities or restrictions in blood vessels.
  • a radiographic contrast medium sometimes referred to simply as contrast
  • the vascular structures in fluid connection with the vein or artery in which the contrast is injected are filled with contrast.
  • X- rays passing through the region of interest are absorbed by the contrast, causing a radiographic outline or image of blood vessels containing the contrast.
  • the resulting images can be displayed on, for example, a monitor and recorded.
  • a patient 100 is positioned in a room that includes an imaging system (not shown) as well as an injection system for injecting contrast and/or saline into the patient.
  • an injection system can include an injector 10 such as the MEDRAD*' Stellanf* CT Injection System available from the Radiology business of the Pharmaceutical Division of Bayer AG of Indianola, Pennsylvania, U.S.A.
  • the injector 10 includes two syringe interfaces 20a and 20b to which two syringes 30a and 30b are removably attachable.
  • Two drive members or pistons 40a and 40b operatively connect to plungers 50a and 50b siidably disposed in syringes 30a and 30b, respectively, to pressurize and inject the fluid therefrom into the patient 100 via a catheter 60 in fluid connection with syringes 30a and 30b.
  • heater jackets 70a and 70b may be provided to maintain the fluid within the syringes 30a and 30b at a predetermined temperature. As shown in FIG. 1, such heater jackets 70a and 70b may each include an arcuate resistance heater portion configured to snap over the cylindrical body of the syringes 30a and 30b.
  • a patient scheduled for a scanning procedure may also be connected to a vital signs monitoring system, such as an ECG monitor 80, via a plurality of electrodes 82 attached to the skin of the patient. Each electrode 82 is connected via a lead 84 to the ECG monitor 80. Electrical noise/disturbancefs) are generated as a result of the use of the injector 10 and related equipment.
  • electrical noise may be generated when the heater jackets 70a and 70b are turned on and off or due to an electrical disturbance (i.e., an ESD field) that may develop during the delivery of a fluid by the injector 10 due to the dissimilarities between the materials used for the barrels of the syringes 30a and 30b (e.g., plastic) and the plungers 50a and 50b (e.g., rubber).
  • This electrical noise can be conveyed from the injector 10 and related equipment to the patient 100 via, for example, a fluid path 55 connecting the injector 10 to the catheter 60, which is conductive by virtue of the contrast medium or saline therein.
  • the present disclosure describes examples of filtering circuitry that, when in use, will be connected in series between ground and a non-magnetic, yet metallic, element, such as a wrist strap, configured to be positioned in contact with a patient.
  • the filtering circuitry which may employ an array of selected capacitors, allows the system to filter to ground the electrical noise generated by the injector and related equipment while the cardiac signals generated by the heart are still picked up by the electrodes of an ECG monitor and conveyed to the ECG monitor for display free of such noise.
  • a system for suppressing electrical noise in an electrocardiogram (ECG) signal displayed on an ECG monitor comprises: a conductive material provided in contact with a surface of a patient; and filtering circuitry connected in series between the conductive material and ground.
  • the filtering circuitry is configured to filter to ground the electrical noise present within the patient.
  • the electrical noise may be generated by at least one electrical device located near the patient, in the examples described hereinafter, the at least one electrical device may be a powered injector and associated devices.
  • the electrical noise may be generated by other electrical devices located near the patient such as a heating device, anesthesiology equipment, or electrosurgical equipment.
  • the conductive material may be provided as a bracelet configured to be worn on a wrist of the patient.
  • the conductive material may be provided on an interior surface of the bracelet with an exterior surface of the bracelet is made from an insulated material.
  • the conductive material is desirably non-magnetic so as not to interfere with medical imaging equipment.
  • the filtering circuitry may be configured as an array of capacitors.
  • the array of capacitors may include four capacitors, each of which having a capacitance of about 0.0047 uF.
  • a specific example of the system comprises a wrist strap positioned around the wrist of a patient and comprising a conductive material provided in contact with a surface of the patient; and filtering circuitry comprising an array of capacitors connected in series between the conductive material of the wrist strap and ground.
  • the filtering circuitry is configured to filter to ground the electrical noise present within the patient that is generated by at least one electrical device located near the patient.
  • a method for suppressing electrical noise in an electrocardiogram (ECG) signal displayed on an ECG monitor comprises: providing a conductive material in contact with a surface of a patient; providing filtering circuitry connected in series between the conductive material and ground; and filtering to ground, with the filtering circuitry, electrical noise present within the patient.
  • ECG electrocardiogram
  • FIG. 1 is a schematic diagram of a conventional arrangement for delivering a fluid to a patient with an injector system during an imaging procedure
  • FIG, 2 is a schematic diagram of an arrangement for delivering a fluid to a patient with an injector system during an imaging procedure that includes a system for suppressing electrical noise in an ECG signal displayed on an ECG monitor in accordance with the present disclosure
  • FIG. 3 is a schematic diagram of an example of the system for suppressing electrical noise in an ECG signal displayed on an ECG monitor in accordance with the present disclosure
  • FIG. 4 is a waveform obtained that illustrates the noise generated when a heater jacket is turned on and off;
  • FIG. 5 is a waveform obtained that illustrates the manner in which the noise generated by the heating jacket is suppressed utilizing the system of the present disclosure
  • FIG. 6 is a waveform obtained that illustrates the noise generated due to an electrical disturbance that develops during the deliver ⁇ ' of a fluid by the injector system due to the dissimilarities between the materials used for the barrels of the syringes and the plungers;
  • FIG. 7 is a waveform obtained that illustrates the manner in which the noise generated by the dissimilarities between the materials of the barrels of the syringes and the plungers is suppressed utilizing the system of the present disclosure.
  • the terms "upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof, shall relate to the device of the present disclosure as it is oriented in the drawing figures.
  • the device of the present disclosure may assume various alternative variations, except where expressly specified to the contrary.
  • the specific devices illustrated in the attached drawings, and described in the following specification are simply exemplary embodiments of the device of the present disclosure. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting.
  • a system is disclosed herein to prevent the noise generated by a powered injector or other electrical equipment located in an operating room from being conducted via the patient (and then the ECG leads) to an ECG monitor.
  • the system routes that noise from the patient through the filtering circuitry discussed hereinafter to ground.
  • the circuitry By filtering the noise before it reaches the ECG leads/monitor, the circuitry essentially suppresses the noise upon its appearance on the patient (i.e., immediately routes that noise from the patient to ground) and prevents it from reaching, and being received by, the ECG leads, and thus prevents the noise from distorting the ECG waveforms that are displayed on the monitor.
  • a patient 100 undergoing a medical imaging procedure is positioned in a room that includes an imaging system (not shown) and an injection system for injecting contrast and/or saline into the patient.
  • the injection system can include an injector 10, such as the MEDRAD ® STELLANT ® injector, that includes two syringe interfaces 20a and 20b to which two syringes 30a and 30b are removably attachable.
  • Two drive members or pistons 40a and 40b operative! ⁇ ' connect to plungers 50a and 50b slidably disposed in syringes 30a and 30b, respectively, to pressurize and inject the fluid therefrom into the patient 100 via a catheter 60 in fluid connection with syringes 30a and 30b.
  • heater jackets 70a and 70b may be provided to maintain the fluid within the syringes 30a and 30b at a predetermined temperature. As shown in FIG. 2, such heater jackets 70a and 70b may each include an arcuate resistance heater portion configured to snap over the cylindrical body of the syringes 30a and 30b.
  • a patient scheduled for a scanning procedure may also be connected to a vital signs monitoring system, such as an ECG monitor 80, via a plurality of electrodes 82 attached to the skin of the patient. Each electrode 82 is connected via a lead 84 to the ECG monitor 80.
  • ECG monitor 80 As discussed hereinabove, electrical noise/disturbance(s) are generated as a result of the use of the injector 10 and related equipment.
  • electrical noise may be generated when the heater jackets 70a and 70b are turned on and off or due to an electrical disturbance (i.e., an ESD field) that may develop during the delivery of a fluid by the injector 10 due to the dissimilarities between the materials used for the barrels of the syringes 30a and 30b (e.g., plastic) and the plungers 50a and 50b (e.g., rubber).
  • This electrical noise can be conveyed from the injector 10 and related equipment to the patient 100 via, for example, the fluid path 55 connecting the injector 10 to the catheter 60, which is conductive by virtue of the contrast medium or saline therein.
  • This noise will be picked up by the electrodes 82 of the ECG monitor 80 and cause a distortion of the ECG signal displayed on the ECG monitor 80 as shown in FIG. 1 unless the noise is routed to ground. Directly grounding the patient would allow for the greatest noise suppression. However, doing so could cause a hazardous condition of an electrical shock if the patient comes into contact with a high current conductor line in the vicinity of the patient. Accordingly, the system of the present disclosure suppresses noise by preventing DC currents from flowing while also providing an impedance to ground that limits the patient leakage current to under a maximum patient leakage current of 500 microamps, which is the maximum allowable current during a single fault under the IEC/EN 60601-1 standard.
  • a system for suppressing electrical noise in an electrocardiogram (ECG) signal displayed on an ECG monitor 80.
  • the system 200 includes a conductive material 202 provided in contact with a surface of the patient 100; and filtering circuitry 204 connected in series between the conductive material 202 and ground 206.
  • the filtering circuitry 204 is configured to filter to ground 206 the electrical noise present within the patient 100 that is generated by the injector 10 and associated equipment located near the patient 100.
  • the distortion 86 of the ECG signals displayed on the ECG monitor as shown in FIG. 1 have been removed because the noise generated by the injector 10 and the associated equipment has been effectively filtered to ground 206 by the filtering circuitry 204.
  • the filtering circuitry 204 may be configured as an array of capacitors 208.
  • the array of capacitors 208 may include four capacitors arranged as shown in FIG. 3.
  • the size of the capacitors 208 is chosen such that the capacitance is high enough to effectively filter the noise generated by the injector 10 while also maintaining an impedance that is high enough to limit the patient leakage current to under the maximum patient leakage current of 500 microamps.
  • An exemplary value of the capacitance for each of the capacitors of the array of capacitors 208 is about 0.0047 uF.
  • the configuration of the array of capacitors 208 shown in FIG. 3 was chosen to provide redundancy to the system. More specifically, by utilizing the configuration for the array of capacitors 208 shown in FIG, 3, if any one of the capacitors 208 fails, the filtering circuitry 204 will continue to function properly to filter noise.
  • the filtering circuitry 204 While one example of the filtering circuitry 204 is specifically illustrated in FIG. 3, this is not to be construed as limiting the present disclosure as other arrangements for the filtering circuitry have been contemplated.
  • the filtering circuitry 204 may be configured as multiple strings of series capacitors, with those strings connected together in parallel .
  • the conductive material 202 of the system 200 may be provided as a bracelet or wrist strap, denoted generally as reference numeral 210, configured to be worn on a wrist of the patient 100.
  • the conductive material 202 may be provided on an interior surface 212 of the bracelet 210 with an exterior surface 214 of the bracelet 210 made from an insulated material 216.
  • the insulated material 216 may take the form of any suitable insulated material such as, but not limited to, plastics, paints, anodization, or other non-conductive surface treatments.
  • a bracelet or wrist strap has been described hereinabove as providing a connection for the conductive material 202 to the patient 100, this is not to be construed as limiting the present disclosure as any suitable manner for providing a resistive connection between the conductive material 202 to the patient 100 may be utilized.
  • the patient 100 may be required to wear a conductive gown that is operatively connected to the filtering circuitry 204.
  • the conductive material 202 may be manufactured from any suitable metallic material .
  • the conductive material 202 is desirably non-magnetic so as not to interfere with medical imaging equipment such as that found within a Magnetic Resonance Imaging (MRI) suite.
  • MRI Magnetic Resonance Imaging
  • Examples of materials that can be utilized as conductive material 202 include, but are not limited to, non-magnetic austenitic stainless steel, aluminum or aluminum alloy with an anti-corrosive but electrically conductive surface treatment, copper with an anti- corrosive but electrically conductive surface treatment, a gold plating on a non-magnetic material, titanium or any other suitable material.
  • FIG. 4 is a waveform that illustrates the noise generated when a heater jacket is turned on and off (i.e., cycled). This noise i s clearly shown by the spike 250 generated when the heater j ackets 70a and 70b are turned on and the spike 252 generated when the heater jackets 70a and 70b are turned off.
  • FIG. 5 another waveform was obtained when the heater jackets 70a and 70b were turned on and off. However, when this waveform was obtained, the patient 100 was connected to ground 206 via the filtering circuitry 204. As can be seen in the waveform illustrated in FIG. 5, the spikes 250 and 252 have been eliminated from the signal represented on the waveform.
  • FIG. 6 is a waveform that illustrates the noise generated during fluid delivery by the injection system due to the dissimilarities between the materials used for the barrels of the syringes 30a and 30b and the plungers 50a and 50b.
  • This noise is clearly shown by the spikes 254 illustrated on the waveform.
  • another waveform was obtained during a fluid injection procedure with the injection system . However, when this waveform was obtained, the patient 100 was connected to ground 206 via the fi ltering circuitry 204. As can be seen in the waveform illustrated in FIG. 7, the spikes 254 have been eliminated from the signal represented on the waveform.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Signal Processing (AREA)
  • Surgery (AREA)
  • Medical Informatics (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Public Health (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Artificial Intelligence (AREA)
  • Physiology (AREA)
  • Computer Vision & Pattern Recognition (AREA)
  • Psychiatry (AREA)
  • Cardiology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)

Abstract

La présente invention décrit un système de suppression du bruit électrique dans un signal d'électrocardiogramme (ECG) affiché sur un moniteur d'ECG comprenant : un matériau conducteur disposé en contact avec une surface d'un patient; et un circuit de filtrage raccordé en série entre le matériau conducteur et la terre. Le circuit de filtrage peut être configuré pour filtrer vers la terre le bruit électrique présent chez le patient.
PCT/US2017/029770 2016-04-29 2017-04-27 Système et procédé de suppression du bruit de signaux électrocardiographiques (ecg) WO2017189807A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP17722602.4A EP3448242A1 (fr) 2016-04-29 2017-04-27 Système et procédé de suppression du bruit de signaux électrocardiographiques (ecg)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US15/142,737 US9757071B1 (en) 2016-04-29 2016-04-29 System and method for suppressing noise from electrocardiographic (ECG) signals
US15/142,737 2016-04-29

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WO2017189807A1 true WO2017189807A1 (fr) 2017-11-02

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US11950934B1 (en) * 2019-06-21 2024-04-09 Verily Life Sciences Llc Input boosting for chopped neural recording systems

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US6958053B1 (en) 1999-11-24 2005-10-25 Medrad, Inc. Injector providing drive member advancement and engagement with syringe plunger, and method of connecting a syringe to an injector
US20140249430A1 (en) * 2003-11-04 2014-09-04 Goverment of the United States, as Represented by the Secretary of the Army Life sign detection and health state assessment system
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EP2823757A1 (fr) * 2013-06-25 2015-01-14 Biosense Webster (Israel), Ltd. Réduction de bruit d'électrocardiogramme

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